Baxter Healthcare Corp.: Medical Device Recall in 2014 - (Recall #: Z-1484-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.

Product Classification:

Class I

Date Initiated: February 7, 2014

Date Posted: April 30, 2014

Recall Number: Z-1484-2014

Event ID: 67523

Reason for Recall:

Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to repeated System Error 322 occurrences.

Status: Terminated

Product Quantity: 277,096 units (revised)

Code Information:

Product Codes: 35700BAX, 35700ABB

Distribution Pattern:

Worldwide Distribution - USA Nationwide including PR and the country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated